CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Nipent (pentostatin) Non-Oncology Policy

Policy governing coverage and prior authorization for Nipent (pentostatin) when used for non-oncology indications (primarily graft-versus-host disease) for Medicaid, Commercial, and Medicare members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyNipent (pentostatin) Non-Oncology Policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateSep 1, 2020

Next Review DateN/A

Key ActionObtain prior authorization and document age (≥18), steroid-refractory acute or chronic GVHD diagnosis, prescriber specialty, and dosing within policy limits.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J9268HCPCS code for pentostatin (10 mg)

≥18Minimum patient age for initial coverage

1.5 mg/m2 x3dAcute GVHD dosing

4 mg/m2 q2wChronic GVHD dosing

Steroid-refractory GVHDIndication covered (non-oncology)

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Coverage Criteria for Nipent (pentostatin)

Initial Therapy

Covered when ALL of the following are met:

Initial Criteria: Adult patient (18 years or older)age >= 18

from policy chunk 4

Initial Criteria: Documented chronic or acute graft-versus-host disease (GVHD) that is steroid-refractoryclinical diagnosis documented

from policy chunk 4

Initial Criteria: Prescribed by a hematologist or oncologistprescriber specialty documented

from policy chunk 4

Initial Criteria: Dose does not exceed policy limits: acute GVHD 1.5 mg/m2 daily for 3 days (may repeat after 2 weeks if needed); chronic GVHD 4 mg/m2 once every 2 weeksdosing within specified limits

from policy chunks 4 and 8

Continuation Therapy

Covered for continuation when ALL of the following are met:

Continuation Criteria: Patient continues to meet initial criteriaongoing documentation

from policy chunk 5

Continuation Criteria: Patient is tolerating treatment with absence of unacceptable toxicityno unacceptable toxicity documented

from policy chunk 5

Neighborhood provides coverage for Nipent (pentostatin) only when used for non-oncology indications that meet the policy’s stated clinical criteria and are recognized as medically accepted indications in standard compendia or peer-reviewed literature. Neighborhood does not provide coverage for drugs when used for investigational purposes or for conditions that are not recognized as medically accepted indications in reference compendia such as AHFS, Micromedex DrugDex, Clinical Pharmacology, Wolters Kluwer Lexi-Drugs, or peer‑reviewed published literature.

Use of Nipent (pentostatin) outside the specific non-oncology guidelines described in this policy (including indications not listed or investigational uses) may be considered not medically necessary and may result in non-payment unless an exception is approved through the authorization process.

Billing Codes

Applicable HCPCS/CPT codeHCPCSCovered

J9268

Injection, pentostatin, 10 mg

Provider Requirements and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests will be reviewed prospectively and must meet the stated clinical criteria (adult patient, documented acute or chronic graft-versus-host disease [GVHD] that is steroid‑refractory, prescribed by a hematologist/oncologist, and dose within guideline limits). Use outside guideline-supported non‑oncology indications may result in non-payment unless approved through the authorization/appeal process.

Adult patients (>= 18 years)
Documented acute or chronic GVHD that is steroid‑refractory
Prescriber: hematologist or oncologist
Dose limits: acute GVHD — 1.5 mg/m2 daily × 3 days (may repeat after 2 weeks if needed); chronic GVHD — 4 mg/m2 once every 2 weeks

Step Therapy

Step Therapy Exception for Prior Users

Medicare members who previously received this medication within the past 365 days are not subject to step therapy requirements.

Key Definitions

Steroid-refractory GVHD — policy definition

DefinitionChronic or acute graft-versus-host disease (GVHD) that has not responded adequately to corticosteroid therapy (steroid-refractory).

Referenced evidenceCompendium support and retrospective series (e.g., MD Anderson study) describe pentostatin use for steroid-refractory GVHD with modest response rates and notable adverse events.

Prescriber expectationPolicy requires prescription by a hematologist or oncologist when used for steroid-refractory GVHD.

Age considerationCovered indication applies to adult patients (18 years or older).

Related dosing guidancePolicy links the steroid-refractory GVHD indication to specified dosing: acute GVHD 1.5 mg/m2 daily for 3 days; chronic GVHD 4 mg/m2 once every 2 weeks.

Background

Pentostatin is an adenosine deaminase inhibitor that causes selective depletion of T lymphocytes and has been used as a therapeutic option for severe T‑cell–mediated immune conditions such as graft‑versus‑host disease (GVHD). In the non‑oncology context described by this policy, pentostatin is reserved for steroid‑refractory GVHD. Clinical evidence supporting this use includes compendium recommendations and small retrospective studies reporting modest response rates but notable adverse events such as nausea, rash, fatigue, leukopenia, and infections. Dosing guidance in the policy differentiates acute and chronic GVHD regimens (see dosing limits): for acute GVHD, the policy specifies 1.5 mg/m2 daily for 3 days (may repeat after 2 weeks if needed); for chronic GVHD, the policy specifies 4 mg/m2 once every 2 weeks.